Guest Editorial: Warning Letters ? A Symptom?

Curia plans to expand its sterile fill/finish capabilities at its Glasgow, UK, site and gives updates on an ongoing expansion at its Albuquerque, NM, site.

In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.

The company gave a first look at its completed expansion at its manufacturing site in Gliwice, Poland during DCAT Week 2025 in New York City.

Metabolic Flux Analysis (MFA) is a powerful technique used to characterize metabolic phenotype driving to improved productivity in biomanufacturing. MFA is most powerful when absolute concentrations of the metabolic intermediates are measured, but doing so in practice is often impractical due to inherent limitations of conventional absolute quantitation by mass spectral analysis. Recently, advances in artificial intelligence (AI) have been applied to solving the problem of broad, untargeted, absolute quantitation in liquid chromatography-mass spectrometry (LC-MS). These new approaches extend readily to the determination of absolute concentrations of stable isotopically-labeled metabolic intermediates, offering a new tool for MFA. Dr Sam Yenne from Metalytics Inc., a company that specializes in the science of metabolic flux, has recently assessed and adopted Pyxis, a new tool for absolute quantitation of raw LC-MS data. Dr Yenne describes MFA, its utility in biopharmaceutical development, associated challenges and how Pyxis impacts those challenges.

The Member Company Announcement Forum is the kickoff event of the annual DCAT Week in New York City, which is being held from March 17–20.

This model is being positioned by Shilpa as a dual approach that offers comprehensive discovery, clinical, and commercial outsourcing services in addition to commercially ready, “off-the-shelf” novel formulations for b2b licensing.